Comparing Erector Spinae and Fascia Iliaca Blocks for Pain Relief After Femur Surgery.

NCT ID: NCT06990958

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2025-08-10

Brief Summary

This clinical study compares two types of nerve blocks used to control pain in adult patients undergoing surgery on the upper (proximal) or middle (midshaft) part of the femur (thigh bone). The two blocks being studied are the Erector Spinae Plane (ESP) block and the Fascia Iliaca Compartment (FIC) block. Both techniques are commonly used in hospitals to reduce postoperative pain.

The goal is to determine which nerve block provides more effective pain relief, reduces the need for opioid medications, and supports faster recovery in patients following femur surgery. Results from this study may improve pain management strategies for similar procedures in the future.

Adults scheduled for proximal or midshaft femur surgery may be eligible to participate. Eligibility is determined based on clinical criteria reviewed by the study team.Administration of one of the two nerve blocks before surgery.Standard surgical and postoperative care.

Monitoring of pain levels at specific time points after surgery

Recording of opioid medication usage

Evaluation of patient satisfaction and any side effects related to the nerve block

Duration:

The intervention (nerve block) is administered once before surgery. Data collection continues during the immediate postoperative period and for a short time following surgery to assess outcomes.

Both nerve blocks are considered safe and are regularly used in clinical practice.

All procedures are performed by qualified clinicians, and safety monitoring is conducted throughout the study.

Participants may experience improved pain relief and reduced need for opioid medications. While direct benefit cannot be guaranteed, information gained from the study may help improve pain management for future patients undergoing similar surgeries.

Participation in the study is completely voluntary. Patients may choose not to participate or may withdraw from the study at any time without affecting the quality of their medical care.

Conditions

Analgesia After Fracture Femur Surgeries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

ESPB Group

patients was placed in the lateral position . the block was performed bz ipsilateral injection of a mixture containing 15mls bupivcaine 0,5% and 20mls normal saline.

Group Type: ACTIVE_COMPARATOR

Erector Spinae Plane Block (ESPB) group

Intervention Type: PROCEDURE

ultrasound guided erector spinae plane block (at lumbar level) in lateral position .

FICB

Patients was placed insupine position . the block performed using a mixture of 15mls bupivcaine 0,5% and 20mls normal saline.

Group Type: ACTIVE_COMPARATOR

Fascia iliaca compartment block (FICB)

Intervention Type: PROCEDURE

ultrasound guided suprainguinal approach in supine position

Interventions

Erector Spinae Plane Block (ESPB) group

ultrasound guided erector spinae plane block (at lumbar level) in lateral position .

Intervention Type: PROCEDURE

Fascia iliaca compartment block (FICB)

ultrasound guided suprainguinal approach in supine position

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• age 18-80
• American society of Anathesiologist physical status ASA Ior II
• Patients undergoing Fixation of femur fractures

Exclusion Criteria

1. Refusal of participation in study.

2. Bleeding disorders (platelets count < 80,000, INR >1.5, Prothrombin concentration < 60%).

3. Skin lesion, wounds or infection at the puncture site. Known allergy to local anesthetic drugs.

4. Known local anesthetic (LA) drug sensitivity. -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Wissam Ahmed Mohamed El Damacey

Lecturer of Anesthesia, surgical ICU and Pain Management Faculty of Medicine, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

kasr alainy hospital -Cairo university , cairo

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-212-2023

Identifier Type: -

Identifier Source: org_study_id